MAUDE Adverse Event Report: Gyrus ACMI, Inc. 150 MICRON TFL BALL TIP SINGLE USE FIBER; Powered Laser Surgical Instrument

Model Number	TFL-FBX150BS
Medical Device Problem Codes	Break (1069); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the single use fiber was broken by the end that plugs into the soltive system.The user fired the laser system without aiming beam present and a small flame was observed and was subsequently extinguished by the scrub nurse.The issue occurred at the beginning of the laser lithotripsy procedure that was completed with a similar device.There was no patient or user harm reported.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

• Brand Name: 150 MICRON TFL BALL TIP SINGLE USE FIBER
• Common Device Name: Powered Laser Surgical Instrument
• Manufacturer (Section D): Gyrus ACMI, Inc.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): Gyrus ACMI, Inc.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50751630
• Report Number: 3011050570-2026-00899
• Device Sequence Number: 10367189
• Product Code: GEX
• UDI-Device Identifier: 00821925043923
• UDI-Public: 00821925043923
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K242191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TFL-FBX150BS
• Device Lot Number: KH508505
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown